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A Study of Vemurafenib in Participants With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01307397
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: Vemurafenib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3219 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma
Actual Study Start Date : March 1, 2011
Actual Primary Completion Date : February 24, 2016
Actual Study Completion Date : February 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Vemurafenib

Arm Intervention/treatment
Experimental: Vemurafenib
Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
Drug: Vemurafenib
Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
Other Name: RO5185426, Zelboraf




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]
    The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable.

  2. Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]
    An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.

  3. Percentage of Participants With AEs of Special Interest [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]
    AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).

  4. Mean Cumulative Dose of Vemurafenib [ Time Frame: Baseline up to end of treatment or death (maximum up to 46 months) ]
  5. Duration of Vemurafenib Treatment [ Time Frame: Baseline up to end of treatment or death (maximum upto 46 months) ]

    Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.

    Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation.


  6. Mean Total Vemurafenib Dose Per Day [ Time Frame: Baseline up to end of treatment or death (maximum up to 46 months) ]

    Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.

    Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment.


  7. Dose Intensity of Vemurafenib [ Time Frame: Baseline up to end of treatment or death (maximum upto 46 months) ]
    Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.


Secondary Outcome Measures :
  1. Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status [ Time Frame: Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months) ]
    ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.

  2. Percentage of Participants Who Received Any Concomitant Medications [ Time Frame: Baseline up to 46 months ]
    Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.

  3. Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]

    BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.

    Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response.


  4. Duration of Response [ Time Frame: From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months]) ]
    The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.

  5. Time to Response [ Time Frame: Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]
    Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.

  6. Percentage of Participants With PD Assessed According to RECIST v1.1 or Death [ Time Frame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]
    PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.

  7. Progression Free Survival (PFS) [ Time Frame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]
    PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.

  8. Percentage of Participants Who Died [ Time Frame: Baseline until death (maximum up to 46 months) ]
  9. Overall Survival (OS) [ Time Frame: Baseline until death (maximum up to 46 months) ]
    Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
  • Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Participants may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
  • Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anti-cancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  • Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307397


  Hide Study Locations
Locations
Albania
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania, 1000
Argentina
Hospital Britanico; Oncologia
Buenos Aires, Argentina, C1280AEB
Fundación CIDEA
Buenos Aires, Argentina, C1425DTG
Inst. Alexander Fleming; Oncologia
Buenos Aires, Argentina, C1426ANZ
Australia, New South Wales
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
Newcastle Mater Misericordiae Hospital; Oncology
Waratah, New South Wales, Australia, 2298
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Border Medical Oncology
Wodonga, New South Wales, Australia, 3690
Australia, Queensland
Greenslopes Private Hospital; Gallipoli Research Centre
Greenslopes, Queensland, Australia, 4120
The Townsville Hospital; Townsville Cancer Centre
Townsville, Queensland, Australia, 4812
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Geelong Hospital; Geelong Cardiology Practice
Geelong, Victoria, Australia, 3220
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, Australia, 3000
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Austria
Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin
Feldkirch, Austria, 6807
LKH Graz; Abteilung für allgemeine Dermatologie
Graz, Austria, 8036
LKH Innsbruck; Universitätsklinik für Dermatologie
Innsbruck, Austria, 6020
Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie
Linz, Austria, 4020
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
LKH Salzburg; Universitätsklinik für Dermatologie
Salzburg, Austria, 5020
Landesklinikum St. Pölten
St. Pölten, Austria, 3100
Medizinische Universität Wien; Univ.Klinik für Dermatologie
Wien, Austria, 1090
Belgium
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Sint Augustinus Wilrijk
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
University Clinical Center of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Nacional de Cancer - INCa; Pesquisa Clinica
Rio de Janeiro, RJ, Brazil, 20230-130
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital A. C. Camargo; Oncologia
Sao Paulo, SP, Brazil, 01509-010
Hospital Sao Jose
São Paulo, SP, Brazil, CEP 01321-001
Bulgaria
District Oncology Dispensary; Department for Oncology and Dermatology
Plovdiv, Bulgaria, 4000
National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
Sofia, Bulgaria, 1756
Canada, Alberta
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Lion'S Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
St. Boniface General Hospital; Medicine
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
QEII HSC; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital; Division of Infectious Diseases
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Quebec City, Quebec, Canada, G1R 2J6
Colombia
Centro Javeriano de Oncología
Bogota, Colombia
Fundacion Santa Fe de Bogotá
Bogota, Colombia
Clínica Imbanaco; Oncology
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Croatia
Clinical Hospital Sisters of Mercy
Zagreb, Croatia, 10000
Czechia
Masarykův onkologický ústav; Klinika komplexní onkologické péče
Brno, Czechia, 656 53
University Hospital; Oncology and Radiotherapy
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Faculty Hospital; Dialysis Unit
Ostrava, Czechia, 708 52
1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus
Praha, Czechia, 128 00
Faculty Hospital Kralovske Vinohrady; Oncology
Praha, Czechia
Denmark
Aarhus Universitetshospital; Kræftafdelingen
Aarhus C, Denmark, 8000
Herlev Hospital; Onkologisk afdeling
Herlev, Denmark, 2730
Odense Universitetshospital, Onkologisk Afdeling R
Odense, Denmark, 5000
Ecuador
Hospital Regional Vicente Corral Moscoso, Servicio de Oncología
Cuenca, Ecuador
Hospital Abel Gilbert Ponton; Oncology
Guayaquil, Ecuador, EC090104
Hospital Solca Portoviejo; Oncologia
Portoviejo, Ecuador, EC130104
Estonia
East Tallinn Central Hospital; Clinic of Internal Medicine
Tallinn, Estonia, 11312
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, Estonia, 13419
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, Estonia, 50406
Finland
Helsinki University Central Hospital; Dept of Oncology
Helsinki, Finland, 00029
Tampere University Hospital; Dept of Oncology
Tampere, Finland, 33520
Turku Uni Central Hospital; Oncology Clinics
Turku, Finland, 20520
Germany
Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik
Aachen, Germany, 52074
Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie
Augsburg, Germany, 86179
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, Germany, 12200
St. Josef-Hospital Klinik f. Dermatologie u. Allergologie
Bochum, Germany, 44791
Elbekliniken Buxtehude; Klinik für Dermatologie
Buxtehude, Germany, 21614
DRK-Krankenhaus; Hautklinik
Chemnitz, Germany, 09117
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf; Hautklinik
Düsseldorf, Germany, 40225
HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
Erfurt, Germany, 99089
Universitätsklinikum Erlangen; Hautklinik
Erlangen, Germany, 91054
Universitätsklinikum Essen
Essen, Germany, 45122
Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie
Frankfurt, Germany, 60596
Uniklinikum Freiburg Dermatol
Freiburg, Germany, 79104
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, Germany, 07548
Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie
Göttingen, Germany, 37075
Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
Hamburg, Germany, 20246
Medizinische Hochschule; Hautklinik Linden
Hannover, Germany, 30449
Uni-Hautklinik
Heidelberg, Germany, 69115
Klinikum am Gesundbrunnen; Tumorzentrum
Heilbronn, Germany, 74078
Universitätsklinikum Jena; Klinik für Hautkrankheiten
Jena, Germany, 07743
Klinikum Kassel; Hautklinik
Kassel, Germany, 34125
UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
Kiel, Germany, 24105
Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
Köln, Germany, 50937
Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie
Leipzig, Germany, 04103
Klinikum d.Stadt Ludwigshafen Hautklinik
Ludwigshafen, Germany, 67063
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, Germany, 23538
Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
Magdeburg, Germany, 39120
Johannes Gutenberg Unis-Klinik; Dept For Dermatology
Mainz, Germany, 55131
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
Mannheim, Germany, 68167
Universitätsklinikum Marburg Klinik f. Dermatologie
Marburg, Germany, 35043
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Minden, Germany, 32429
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
München, Germany, 80337
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
München, Germany, 80804
Universitätsklinikum Münster
Münster, Germany, 48149
Fachklinik Hornheide; Internistische Onkologie
Münster, Germany, 48157
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Nürnberg, Germany, 90419
Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
Quedlinburg, Germany, 06484
KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen
Recklinghausen, Germany, 45657
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
Regensburg, Germany, 93053
Universitaets-Hautklinik Tuebingen
Tübingen, Germany, 72076
Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie
Wiesbaden, Germany, 65191
HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin
Wuppertal, Germany, 42283
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
Würzburg, Germany, 97080
Greece
Laiko General Hospital; 1St Pathological Clinic
Athens, Greece, 115 27
Hospital Hygeia; 1St Oncology Dept.
Athens, Greece, 15123
Univ General Hosp Heraklion; Medical Oncology
Heraklion, Greece, 711 10
Metropolitan Hospital; Dept. of Oncology
Piraeus, Greece, 185 47
Hungary
Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
Budapest, Hungary, 1085
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, Hungary, 1122
Debreceni Egyetem OEC; Borgyogyaszati Klinika
Debrecen, Hungary, 4012
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
Pecs, Hungary, 7632
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
Szeged, Hungary, 6720
India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, Delhi, India, 110085
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India, 400012
Curie Manavata Cancer Centre
Nashik, Maharashtra, India, 422004
Basavatarakam Indo-American Cancer Hospital & Research Institute
Hyderabad, India, 500034
Chhatrapati Shahuji Maharaj Medical University; Department of Oncology
Lucknow, India, 226003
Regional Cancer Centre; Dept of Oncology
Trivandrum, India, 695 011
Christian Med Clg & Hspt
Vellore, India, 632004
Ireland
Cork Uni Hospital; Oncology Dept
Cork, Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, Ireland, 4
Mater Misericordiae Uni Hospital; Oncology
Dublin, Ireland, 7
Mater Private Hospital
Dublin, Ireland, 7
St James' Hospital; Cancer Clinical Trials Office
Dublin, Ireland
Galway Uni Hospital; Oncology Dept
Galway, Ireland
University Hospital Limerick - Oncology
Limerick, Ireland
Waterford Regional Hospital; Department Of Medical Oncology
Waterford, Ireland
Israel
Soroka Medical Center; Oncology Dept
Beer Sheva, Israel, 8410101
Ranbam Health Care Campus; Oncology - Hafia
Hafia, Israel, 3109601
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 91120-01
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy, 41100
AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
Reggio Emilia, Emilia-Romagna, Italy, 42100
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
Roma, Lazio, Italy, 00167
IFO - Istituto Regina Elena; Oncologia Medica
Roma, Lazio, Italy, 00168
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova, Liguria, Italy, 16132
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardia, Italy, 24128
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardia, Italy, 25123
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano, Lombardia, Italy, 20141
Policlinico Le Molinette; Clinica Dermatologica
Torino, Piemonte, Italy, 10126
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
Bari, Puglia, Italy, 70126
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Palermo, Sicilia, Italy, 90127
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Firenze, Toscana, Italy, 50139
Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina
Pisa, Toscana, Italy, 50126
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Toscana, Italy, 53100
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, Italy, 05100
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova, Veneto, Italy, 35128
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, Korea, Republic of, 110-744
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Asan Medical Center.
Seoul, Korea, Republic of, 138-736
Latvia
Daugavpils Regional Hospital
Daugavpils, Latvia, 5417
Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Riga, Latvia, LV 1079
Lithuania
Klaipeda University Hospital
Klaipeda, Lithuania, 92288
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
Vilnius, Lithuania, 08661
Macedonia, The Former Yugoslav Republic of
University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
Leon, Mexico, 37000
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, Mexico, 14000
Hospital General de México; Unidad de Oncologia
Mexico DF, Mexico, 06726
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
Amsterdam, Netherlands, 1066 CX
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, Netherlands, 1081 HV
Tergooiziekenhuizen
Blaricum, Netherlands, 1261 AN
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, Netherlands, 9713 GZ
Academisch Ziekenhuis Leiden; Clinical Oncology
Leiden, Netherlands, 2333 ZA
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, Netherlands, 6229 HX
UMC St Radboud; Interne Oncologie; Medical Oncology Department
Nijmegen, Netherlands, 6500 HB
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
Utrecht, Netherlands, 3584 CX
Norway
Haukeland Universitetshospital; Onkologisk Avd.
Bergen, Norway, 5021
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, Norway, 0379
Peru
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, Peru, 04001
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, Poland, 31-531
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
Olsztyn, Poland, 10-228
NZOZ Med.-Polonia sp. z o.o.
Poznań, Poland, 60-693
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
Warszawa, Poland, 02-781
Portugal
IPO de Lisboa; Servico de Oncologia Medica
Lisboa, Portugal, 1099-023
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Romania
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Bucuresti, Romania, 022328
Medisprof SRL
Cluj-Napoca, Romania, 400058
S.C. Life Search S.R.L; Medical Oncology Clinic
Timisoara, Romania, 300167
Russian Federation
FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
St Petersburg, Leningrad, Russian Federation, 197758
Regional Clinical Oncology Dispensary
Krasnodar, Russian Federation, 350040
Russian Cancer Research Center
Moscow, Russian Federation, 115478
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Stavropol Clinical Oncology Dispansary
Stavropol, Russian Federation, ND
Bashkirian Republican Clinical Oncology Dispensary
UFA, Russian Federation, 450054
Serbia
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa; Oncology
Belgrade, Serbia, 11080
Slovakia
Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie
Bratislava, Slovakia, 812 50
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
Bratislava, Slovakia, 833 10
POKO Poprad; Department of Oncology
Poprad, Slovakia, 058 01
Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
South Africa
Universitas Annex, University of the Free State; Clinical Oncology
Bloemfontein, South Africa, 9300
Cape Town Oncology Trials
Cape Town, South Africa, 7570
Cancercare
Cape Town, South Africa, 7700
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, South Africa, 2196
Steve Biko Academic Hospital; Oncology
Pretoria, South Africa, 0002
Sandton Oncology Centre
Sandton, South Africa, 2196
Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Asturias, Spain, 33011
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Hospital Universitario de Santa Lucía; Servicio de Oncología Médica
Cartagena (Murcia), Murcia, Spain, 30202
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Xeral Cíes; Servicio de Oncologia
Vigo, Pontevedra, Spain, 36312
Hospital Universitario de Canarias (HUC)
La Laguna (Tenerife), Tenerife, Spain, 38320
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, Spain, 48903
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital Reina Sofia
Cordoba, Spain, 14004
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, Spain, 18014
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña, Spain, 15006
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
Leon, Spain, 24071
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, Spain, 41014
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, Spain, 46009
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sweden
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, Sweden, SE-41 343
Skånes Onkologiska Klinik, Universitetssjukhuset
Lund, Sweden, 22185
Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden, 171 76
Norrlands universitetssjukhus; Onkologkliniken
Umeå, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 75185
Switzerland
Universitaetsspital Basel; Onkologie
Basel, Switzerland, 4031
Inselspital Bern; Medizinische Onkologie
Bern, Switzerland, 3010
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, Switzerland, 7000
CHUV; Departement d'Oncologie
Lausanne, Switzerland, 1011
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen, Switzerland, 9007
Universitätsspital Zürich; Dermatologische Klinik
Zürich, Switzerland, 8091
Turkey
Adana Baskent University Hospital; Medical Oncology
Adana, Turkey, 01120
Cukurova Uni Faculty of Medicine; Medical Oncology
Adana, Turkey, 01330
Ankara Uni , Ibn-I Sina Hospital; Oncology Dept
Ankara, Turkey, 06230
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey, 06500
Akdeniz University School of Medicine; General Surgery
Antalya, Turkey, 07000
Ege University Medical Faculty; Medical Oncology Department
Bornova, İZMİR, Turkey, 35100
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, Turkey, 27310
Kartal Training and Research Hospital;Medical Oncology Department
Istanbul, Turkey, 34000
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
American Hospital, Medical Oncology Department
Istanbul, Turkey, 34365
Dokuz Eylul Uni ; Medical Oncology
Izmir, Turkey, 35340
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge, United Kingdom, CB2 0QQ
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, United Kingdom, GU2 7XX
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, United Kingdom, NE7 7DN
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, United Kingdom, HA6 2RN
Nottingham University Hospitals City Campus
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, United Kingdom, OX3 7LJ
Southampton General Hospital; Medical Oncology
Southampton, United Kingdom, SO16 6YD
Singleton Hospital; Oncology
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
2010-023526-21 ( EudraCT Number )
First Posted: March 2, 2011    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vemurafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action